Product Classification

• Device: device, beam limiting, teletherapy, radionuclide
• Regulation Description: Radionuclide radiation therapy system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IWD
• Submission Type: 510(k)
• Regulation Number: 892.5750
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 62083 Edition 2.0 2009-09 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
• IEC 61674(1997)(2002) Amendment 1, Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging
• IEC 60601-2-11 (1997)(2004) Amendment 1 - Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
• IEC 60731 Edition 3.0 2011-02 Amendment 1, Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
• IEC 61217 (2008) Radiotherapy equipment - Coordinates, movements, and scales Consolidated Edition 1.2

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.